A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (NEWBORN-1)

• ClinicalTrials.gov Identifier: NCT02377466
• Recruitment Status: Terminated
• First Posted: March 3, 2015
• Results First Posted: July 19, 2018
• Last Update Posted: July 28, 2020
• Sponsor: GlaxoSmithKline
• Collaborator: PPD
• Information provided by (Responsible Party): GlaxoSmithKline

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Obstetric Labour, Premature
• Interventions: Drug: Retosiban IV infusion; Drug: Placebo IV infusion
• Enrollment: 25

Participant Flow

Recruitment Details	NEWBORN-1 was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to investigate efficacy and safety of retosiban in female participants aged 12 to 45 years with an uncomplicated singleton pregnancy in preterm labor with intact membranes between 24 0/7 and 33 6/7 weeks gestation. The study was conducted in 3 countries.
Pre-assignment Details	Twenty-five participants were randomly assigned to study treatments: 12 participants to retosiban intravenous (IV) infusion and 13 participants to matched placebo IV infusion. Two participants randomized to retosiban arm did not receive study treatment. The study was terminated early due to feasibility of recruiting the study in a timely manner.

Arm/Group Title	Placebo	Retosiban
Arm/Group Description	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Period Title: Overall Study
Started	13	12
Treated	13	10
Completed	13	10
Not Completed	0	2
Reason Not Completed
Other: Randomized and not treated	0	2

Baseline Characteristics

Arm/Group Title		Placebo	Retosiban	Total
Arm/Group Description		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Total of all reporting groups
Overall Number of Baseline Participants		13	10	23
Baseline Analysis Population Description		Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	13 participants	10 participants	23 participants
		26.5 (6.78)	27.7 (6.73)	27.0 (6.63)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	13 participants	10 participants	23 participants
	Female	13 100.0%	10 100.0%	23 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	13 participants	10 participants	23 participants
African American/African Heritage		2 15.4%	2 20.0%	4 17.4%
Asian-Central/South Asian Heritage		0 0.0%	1 10.0%	1 4.3%
Asian-East Asian Heritage		1 7.7%	0 0.0%	1 4.3%
Asian-Japanese Heritage		4 30.8%	2 20.0%	6 26.1%
Asian-South East Asian Heritage		1 7.7%	0 0.0%	1 4.3%
White-White/Caucasian/European Heritage		5 38.5%	5 50.0%	10 43.5%

Outcome Measures

1. Primary Outcome

Title	Time to Delivery or Treatment Failure, Whichever Occurs First
Description	Time to delivery or treatment failure is the number of days from the first dose of study treatment until delivery or treatment failure whichever occurs first. Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Statistical analysis was not performed due to early termination of the study and resultant small sample size.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Mean (Standard Deviation); Unit of Measure: Days
	11.10 (14.987)	18.91 (22.993)

2. Primary Outcome

Title	Number of Neonates With Any Diagnosis From the Neonatal Morbidity and Mortality Composite Component
Description	The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, respiratory distress syndrome (RDS), bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, intraventricular hemorrhage (IVH), white matter injury and cerebellar hemorrhage. Neonates with any of the composite component has been presented. Statistical analysis was not performed due to early termination of study and resultant small sample size. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.
Time Frame	Up to 28 days after the estimated date of delivery (EDD) of 40 0/7 weeks

Outcome Measure Data

Analysis Population Description

Neonatal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	4	2

3. Secondary Outcome

Title	Time to Delivery
Description	The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The mean number of days to delivery along with standard deviation has been presented.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Mean (Standard Deviation); Unit of Measure: Days
	16.32 (18.595)	19.18 (22.770)

4. Secondary Outcome

Title	Number of Participants With Births Prior to 37 0/7 Weeks Gestation
Description	Gestational age at birth (weeks) is defined as the gestational age when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm, if the gestational age at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented.
Time Frame	Up to 13 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	9	8

5. Secondary Outcome

Title	Number of Participants With Births at Term
Description	Participants were considered to have delivered at term if the gestational age was >=37 0/7. The number of participants who delivered at term, that is, 37 0/7 to 41 6/7 weeks gestation has been presented.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	4	2

6. Secondary Outcome

Title	Length of Neonatal Hospital Stay
Description	The length of stay was collected from medical records and was calculated as the days between the delivery date and time and discharge date and time.
Time Frame	Up to 28 days post EDD of 40 0/7 weeks gestation

Outcome Measure Data

Analysis Population Description

Neonatal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Mean (Standard Deviation); Unit of Measure: Days
	37.50 (34.537)	26.05 (32.689)

7. Secondary Outcome

Title	Number of Participants With Births Prior to 35 0/7 Weeks Gestation
Description	The number of participants who delivered prior to 35 0/7 weeks gestation has been presented.
Time Frame	Up to 11 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	9	7

8. Secondary Outcome

Title	Number of Participants With Births Prior to 32 0/7 Weeks Gestation
Description	The number of participants who delivered prior to 32 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 32 0/7 week's gestation and delivered were included.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	9	6
Measure Type: Number; Unit of Measure: Participants
	6	2

9. Secondary Outcome

Title	Number of Participants With Births Prior to 28 0/7 Weeks Gestation
Description	The number of participants who delivered prior to 28 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 28 0/7 week's gestation and delivered were included.
Time Frame	Up to 4 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	2	2
Measure Type: Number; Unit of Measure: Participants
	2	1

10. Secondary Outcome

Title	Number of Participants With Births <=7 Days From the First Study Treatment
Description	The number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.
Time Frame	Up to 7 days

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	5	5

11. Secondary Outcome

Title	Number of Participants With Births at <=48 Hours From the First Study Treatment
Description	The number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.
Time Frame	Up to 48 hours

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	3	3

12. Secondary Outcome

Title	Number of Participants With Births at <=24 Hours From the First Study Treatment
Description	The number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.
Time Frame	Up to 24 hours

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	3	1

13. Secondary Outcome

Title	Number of Neonates With Any of the Co-primary Composite Neonatal Morbidity and Mortality, Excluding RDS
Description	The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with any co-primary composite neonatal morbidity and mortality component, excluding RDS has been presented.
Time Frame	Up to 28 weeks after EDD (40 weeks gestation)

Outcome Measure Data

Analysis Population Description

Neonatal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	3	0

14. Secondary Outcome

Title	Number of Neonates With Each Individual Component of the Composite Neonatal Morbidity and Mortality
Description	The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with each individual component of the composite component has been presented.
Time Frame	Up to 28 days after the EDD of 40 0/7 weeks

Outcome Measure Data

Analysis Population Description

Neonatal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
Fetal Death	0	0
Neonatal Death	0	0
RDS	3	2
Bronchopulmonary dysplasia	3	0
Necrotizing enterocolitis or Isolated Perforation	0	0
Sepsis	0	0
Meningitis	0	0
Retinopathy of prematurity	0	0
IVH	0	0
White Matter Injury	0	0
Cerebellar Hemorrhage	0	0

15. Secondary Outcome

Title	Number of Neonatal Participants With Admission to a Particular Hospital Unit
Description	Neonatal healthcare resource utilization was collected from review of medical records. The number of neonatal participants who were admitted to a particular hospital unit that is, level III (or higher) intensive neonatal care (NICU), Intensive care unit (ICU), general ward, Level I - Basic Neonatal care, Well born nursery (SCBU) and Level II-Special Care Newborn nursery high dependency (NHDU) has been summarized. Neonatal Safety Population consisted of neonates whose mothers received study treatment.
Time Frame	Up to 28 days post EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
Level III (or higher) NICU	5	6
Intensive care unit	0	1
General Ward	2	2
Level II-Special Care NHDU	0	1
Missing	1	0
Multiple ward type	5	0

16. Secondary Outcome

Title	Length of Stay in Specialized Care Unit
Description	Neonatal healthcare resource utilization was collected from review of medical records. The length of stay in a specialized care unit (NICU or ICU) has been presented for neonatal participants with admission to ICU or NICU.
Time Frame	Up to 28 days post EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population.

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	10	7
Mean (Standard Deviation); Unit of Measure: Days
	40.34 (35.475)	35.60 (35.308)

17. Secondary Outcome

Title	Number of Newborn Participants With Hospital Readmission
Description	Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. The number of newborn participants who had readmission to hospital is presented.
Time Frame	Up to 28 days of EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	0	0

18. Secondary Outcome

Title	Length of Stay Following Readmission to Hospital
Description	Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. Length of stay in hospital following readmission is presented for neonates.
Time Frame	Up to 28 days after EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Median (Full Range); Unit of Measure: Days
	0; (0 to 0)	0; (0 to 0)

19. Secondary Outcome

Title	Number of Participants With Ambulatory Surgery
Description	Information regarding participants who had ambulatory surgery was collected from the newborn medical records. The number of neonatal participants with ambulatory surgery is presented.
Time Frame	Up to 28 days post EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	0	0

20. Secondary Outcome

Title	Time to Treatment Failure
Description	Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. Time to treatment failure is the number of days from the first dose of study treatment until treatment failure. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Only those maternal participants with treatment failure were included in the analysis. NA indicates standard deviation could not be calculated as only one participant was analyzed.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Maternal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	4	1
Mean (Standard Deviation); Unit of Measure: Days
	1.141 (1.4307)	0.899 [1] (NA)

[1]

Standard deviation could not be calculated as only one participant was analyzed.

21. Secondary Outcome

Title	Number of Participants Who Received Any Putative Tocolytic
Description	A putative tocolytic medication was the medication administered for active preterm labor or as prevention of preterm labor and included calcium channel blockers, nonsteroidal anti-inflammatory drugs, or beta agonists, or magnesium sulfate doses that exceeded prespecified IV loading doses, infusion rates, or total duration of administration.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	4	1

22. Secondary Outcome

Title	Number of Participants With Subsequent Preterm Labor
Description	The participants who had not delivered after 48 hours post-infusion were contacted to determine if they had delivered or experienced any subsequent episodes of preterm labor. A subsequent episode of preterm labor was only recorded if the participant reported it to the Principal Investigator during one of the telephone follow-up calls but did not then go on to immediately deliver. However, if labor started and led to immediate delivery, then the only data collected would be the pre-specified delivery data and thus would not be counted as a subsequent episode of preterm labor. The number of participants who had a subsequent episode of preterm labor after administration of the study treatment has been presented. Maternal Safety Population comprised of all maternal participants randomly assigned to treatment who have been exposed to study treatment.
Time Frame	Up to 11 weeks

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	1	1

23. Secondary Outcome

Title	Number of Maternal Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that mey require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one AE and one SAE has been presented.
Time Frame	Up to 6 weeks after delivery

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
AEs	6	6
SAEs	0	0

24. Secondary Outcome

Title	Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Description	SBP and DBP were measured with participants in a semirecumbent or seated position. SBP and DBP were measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 9 days

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: millimeter of mercury (mmHg)
DBP; Day 1: 15 to 30 minutes; n=13, 10	Number Analyzed	13 participants	10 participants
		-3.2 (10.64)	-6.8 (8.22)
DBP; Day 1: 4 to 8 hours; n=11, 10	Number Analyzed	11 participants	10 participants
		-9.0 (11.31)	-7.0 (10.14)
DBP; Day 1: 20 to 24 hours; n=10, 8	Number Analyzed	10 participants	8 participants
		-13.1 (11.05)	-6.5 (8.65)
DBP; Day 2; n=11, 7	Number Analyzed	11 participants	7 participants
		-10.2 (11.07)	-4.0 (6.66)
DBP; Post infusion assessment; n=9, 5	Number Analyzed	9 participants	5 participants
		-6.6 (12.69)	-2.8 (4.76)
SBP; Day 1: 15 to 30 minutes; n=13, 10	Number Analyzed	13 participants	10 participants
		-0.8 (7.50)	-3.1 (10.40)
SBP; Day 1: 4 to 8 hours; n=11, 10	Number Analyzed	11 participants	10 participants
		-7.1 (13.09)	-1.3 (9.06)
SBP; Day 1: 20 to 24 hours; n=10, 8	Number Analyzed	10 participants	8 participants
		-5.2 (12.47)	2.6 (14.56)
SBP; Day 2; n=11, 7	Number Analyzed	11 participants	7 participants
		-4.5 (11.86)	0.7 (10.21)
SBP; Post infusion assessment; n=9, 5	Number Analyzed	9 participants	5 participants
		-9.6 (8.69)	-7.0 (8.22)

25. Secondary Outcome

Title	Change From Baseline in Heart Rate
Description	Heart rate was measured with the participants in a semirecumbent or seated position. Heart rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 9 days

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: beats per minute
Day 1: 15 to 30 minutes; n=13, 10	Number Analyzed	13 participants	10 participants
		-5.1 (12.37)	1.4 (8.13)
Day 1: 4 to 8 hours; n=11, 10	Number Analyzed	11 participants	10 participants
		-2.6 (10.82)	-0.3 (8.12)
Day 1: 20 to 24 hours; n=9, 8	Number Analyzed	9 participants	8 participants
		-4.1 (10.61)	6.5 (21.64)
Day 2; n=11, 7	Number Analyzed	11 participants	7 participants
		-5.6 (15.73)	-3.6 (13.91)
Post infusion assessment; n=9, 5	Number Analyzed	9 participants	5 participants
		-6.1 (17.80)	-3.8 (16.24)

26. Secondary Outcome

Title	Change From Baseline in Temperature
Description	Temperature was measured with the participants in a semirecumbent or seated position. Temperature was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: degree Celsius
Day 1: 15 to 30 minutes; n=12, 9	Number Analyzed	12 participants	9 participants
		-0.028 (0.4123)	-0.111 (0.1900)
Day 1: 4 to 8 hours; n=11, 10	Number Analyzed	11 participants	10 participants
		0.087 (0.3947)	-0.144 (0.3594)
Day 1: 20 to 24 hours; n=10, 8	Number Analyzed	10 participants	8 participants
		0.104 (0.5413)	-0.043 (0.3174)
Day 2; n=11, 7	Number Analyzed	11 participants	7 participants
		0.105 (0.5067)	0.051 (0.2062)
Post-infusion assessment; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.136 (0.4668)	0.072 (0.2234)

27. Secondary Outcome

Title	Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured with the participants in a semirecumbent or seated position. Respiratory rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: breaths per minute
Day 1: 15 to 30 minutes; n=11, 8	Number Analyzed	11 participants	8 participants
		0.5 (3.45)	-1.1 (2.90)
Day 1: 4 to 8 hours; n=8, 9	Number Analyzed	8 participants	9 participants
		1.1 (3.83)	-1.1 (2.15)
Day 1: 20 to 24 hours; n=9, 7	Number Analyzed	9 participants	7 participants
		0.3 (2.35)	-1.0 (2.77)
Day 2; n=10, 6	Number Analyzed	10 participants	6 participants
		0.9 (4.01)	0.0 (1.79)
Post infusion assessment; n=8, 4	Number Analyzed	8 participants	4 participants
		0.4 (4.27)	0.5 (2.52)

28. Secondary Outcome

Title	Change From Baseline in Hematocrit Levels
Description	Blood samples were collected for the evaluation of change in hematocrit levels from Baseline. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		-0.0343 (0.04324)	-0.0470 (0.02773)
Post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-0.0090 (0.02900)	-0.0078 (0.02928)

29. Secondary Outcome

Title	Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC)
Description	Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: grams per liter (g/L)
Hemoglobin; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		-11.2 (11.20)	-15.7 (6.66)
Hemoglobin; Post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-1.0 (9.76)	-1.6 (8.79)
MCHC; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		-0.3 (17.27)	-2.7 (10.97)
MCHC; Post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		5.0 (8.52)	2.6 (5.41)

30. Secondary Outcome

Title	Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count
Description	Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: Billion cells per liter (L)
Basophils; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		-0.003 (0.0132)	0.000 (0.0458)
Basophils; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		0.003 (0.0160)	0.058 (0.1103)
Eosinophils; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		0.004 (0.0938)	-0.063 (0.0513)
Eosinophils; post-infusion assessment; 7, 5	Number Analyzed	7 participants	5 participants
		0.064 (0.1321)	-0.044 (0.1328)
Lymphocytes; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		0.323 (0.6117)	0.877 (0.1914)
Lymphocytes; post-infusion assessment; 7, 5	Number Analyzed	7 participants	5 participants
		0.253 (1.0579)	1.006 (1.4223)
Monocytes; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		0.008 (0.3389)	0.147 (0.5773)
Monocytes; post-infusion assessment; 7, 5	Number Analyzed	7 participants	5 participants
		0.141 (0.2535)	-0.082 (0.4135)
Neutrophils; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		2.744 (6.9362)	-1.813 (3.3001)
Neutrophils; post-infusion assessment; 7, 5	Number Analyzed	7 participants	5 participants
		-2.246 (6.0323)	-1.910 (2.8497)
Platelets; Day 2; n=8, 3	Number Analyzed	8 participants	3 participants
		-6.4 (47.42)	-24.7 (32.58)
Platelets; post-infusion assessment; 6, 5	Number Analyzed	6 participants	5 participants
		-15.7 (60.48)	-5.4 (33.34)
Leukocytes; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		3.10 (6.720)	-0.87 (2.914)
Leukocytes; post-infusion assessment; 7, 5	Number Analyzed	7 participants	5 participants
		-1.76 (5.358)	-0.98 (2.645)

31. Secondary Outcome

Title	Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV)
Description	Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: femtoliter (fL)
MCV; Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		0.4 (2.79)	1.7 (4.73)
MCV; Post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-1.9 (1.77)	-0.8 (1.30)
MPV; Day 2; n=8, 3	Number Analyzed	8 participants	3 participants
		-0.11 (0.455)	-0.20 (0.436)
MPV; Post-infusion assessment; n=6, 5	Number Analyzed	6 participants	5 participants
		0.02 (0.833)	0.48 (1.026)

32. Secondary Outcome

Title	Change From Baseline in Erythrocyte Level
Description	Blood samples were collected for the evaluation of change in erythrocyte level from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: Trillion cells per liter
Day 2; n=9, 3	Number Analyzed	9 participants	3 participants
		-0.39 (0.423)	-0.53 (0.153)
Post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-0.03 (0.330)	-0.02 (0.303)

33. Secondary Outcome

Title	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels
Description	Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: International Units per liter (IU/L)
ALP; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-17.3 (17.56)	-11.8 (6.46)
ALP; post-infusion assessment; n=8, 6	Number Analyzed	8 participants	6 participants
		6.6 (31.14)	-2.8 (14.08)
ALT; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		3.9 (19.60)	4.4 (10.64)
ALT; post-infusion assessment; n=8, 6	Number Analyzed	8 participants	6 participants
		-8.8 (20.04)	2.5 (5.50)
AST; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		4.4 (15.69)	2.0 (10.20)
AST; post-infusion assessment; n=8, 6	Number Analyzed	8 participants	6 participants
		-9.1 (13.05)	-0.5 (7.45)
GGT; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.9 (1.69)	-0.8 (1.30)
GGT; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		4.4 (2.57)	0.4 (2.07)
LDH; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-6.7 (33.51)	-26.4 (31.86)
LDH; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-8.1 (21.93)	-7.6 (31.76)

34. Secondary Outcome

Title	Change From Baseline in Albumin and Protein Levels
Description	Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: grams per liter (g/L)
Albumin; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-3.4 (3.68)	-2.6 (1.67)
Albumin; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-1.3 (2.21)	-1.0 (2.35)
Protein; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-5.8 (6.26)	-5.4 (3.58)
Protein; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-2.4 (3.41)	-1.8 (5.02)

35. Secondary Outcome

Title	Change From Baseline in Anion Gap, Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level
Description	Blood samples were collected for the evaluation of change from Baseline in levels of anion gap, calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: millimoles per liter (mmol/L)
Anion Gap; Day 2; n=8, 4	Number Analyzed	8 participants	4 participants
		0.0 (4.72)	0.0 (1.83)
Anion Gap; post-infusion assessment; n=7, 4	Number Analyzed	7 participants	4 participants
		-1.6 (5.26)	0.3 (2.22)
Calcium; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.042 (0.2833)	-0.040 (0.1208)
Calcium; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		0.091 (0.2052)	-0.048 (0.1016)
Chloride; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		1.0 (5.17)	1.8 (2.17)
Chloride; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-0.7 (3.35)	-0.6 (2.30)
Carbon Dioxide; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.2 (3.63)	0.0 (2.35)
Carbon Dioxide; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		2.3 (3.64)	-0.2 (2.77)
Glucose; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		1.47 (1.639)	1.98 (1.064)
Glucose; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		0.11 (2.497)	0.28 (2.109)
Potassium; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.16 (0.394)	0.10 (0.515)
Potassium; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-0.16 (0.237)	0.10 (0.283)
Magnesium; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.411 (0.9476)	-0.236 (0.5428)
Magnesium; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		-0.449 (0.6473)	-0.056 (0.6199)
Phosphate; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.133 (0.1768)	0.030 (0.2928)
Phosphate; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		0.021 (0.2018)	0.110 (0.1557)
Sodium; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		1.4 (2.96)	0.4 (1.67)
Sodium; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		0.1 (2.12)	-0.8 (1.64)

36. Secondary Outcome

Title	Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels
Description	Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame	Baseline and up to 1 week

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: micromoles per liter (µmol/L)
Direct Bilirubin; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		0.0 (1.00)	-0.4 (0.89)
Direct Bilirubin; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		0.3 (0.76)	-0.4 (0.89)
Bilirubin; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.7 (1.41)	-0.8 (1.10)
Bilirubin; post-infusion assessment; n=8, 6	Number Analyzed	8 participants	6 participants
		-0.3 (1.28)	-2.0 (3.10)
Indirect Bilirubin; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		-0.7 (1.41)	-0.4 (1.67)
Indirect Bilirubin; post-infusion assessment;n=7,5	Number Analyzed	7 participants	5 participants
		-0.6 (1.51)	-1.6 (3.85)
Creatinine; Day 2; n=6, 3	Number Analyzed	6 participants	3 participants
		-0.33 (6.812)	2.37 (1.429)
Creatinine; post-infusion assessment; n=6, 3	Number Analyzed	6 participants	3 participants
		1.92 (5.075)	-0.33 (2.695)
Urate; Day 2; n=9, 5	Number Analyzed	9 participants	5 participants
		1.1 (24.72)	-22.0 (13.04)
Urate; post-infusion assessment; n=7, 5	Number Analyzed	7 participants	5 participants
		12.9 (24.30)	-2.0 (40.25)

37. Secondary Outcome

Title	Number of Participants Who Discontinued Study Treatment Due to Clinical and Laboratory Toxicities
Description	Number of maternal participants who discontinued study treatment due to clinical and laboratory toxicities is presented.
Time Frame	Up to 48 hours post-infusion

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	0	0

38. Secondary Outcome

Title	Number of Maternal Participants With a Score of 12 or Higher on the Edinburgh Postnatal Depression Scale (EPDS)
Description	The effect of preterm birth on maternal health status was assessed using the EPDS. The EPDS is a 10-item self-reported assessment of depression, validated for administration during both the antenatal and the post-natal periods. Items are rated on a 4-point variable Likert scale, ranging from 0 to 3. The total score was calculated by adding individual scores for each item and ranged from 0 to 30. A score of less than 8 indicates depression not likely; score of 9 to 11 indicates possible depression and a score of more than 12 indicates an increased probability of depression. Maternal participants were required to complete the EPDS at the maternal follow-up assessment 6 weeks post-delivery.
Time Frame	Up to 6 weeks post delivery

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	2	0

39. Secondary Outcome

Title	Number of Maternal Participants With AEs of Special Interest (AESI).
Description	Maternal AESI included: maternal death; chorioamnionitis and its complications (clinical chorioamnionitis, preterm premature rupture of membranes, endomyometritis, wound infection, pelvic abscess, bacteremia, septic shock, disseminated intravascular coagulation, and adult RDS); placental abruption; postpartum hemorrhage - postpartum hemorrhage and/or retained placenta and pulmonary edema. The number of participants with at least one AESI has been presented.
Time Frame	Up to 6 weeks post-delivery

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	0	1

40. Secondary Outcome

Title	Number of Maternal Participants With Disease Related AEs (DRE)
Description	Maternal DREs included: signs and symptoms of labor discomfort (example, cramping, backache, muscle aches, nausea); subsequent episodes of preterm labor and hospitalization for delivery. The number of participants with at least one DRE has been presented.
Time Frame	Up to 6 weeks post-delivery

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	0	1

41. Secondary Outcome

Title	Number of Fetal Participants With AEs and SAEs Prior to Delivery
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Fetal AEs and SAEs included the adverse events that were experienced by the fetus prior to delivery. The number of fetal participants who experienced at least one AE and one SAE has been presented.
Time Frame	Up to 17 weeks post-infusion

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
AE	3	5
SAE	0	1

42. Secondary Outcome

Title	Number of Participants With Fetal Acidosis
Description	The number of participants with fetal acidosis is presented.
Time Frame	Up to 16 weeks

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	0	0

43. Secondary Outcome

Title	Number of Participants With Fetal AESI
Description	Fetal AESI included: intrauterine fetal demise; category II or III fetal heart rate tracing; and fetal inflammatory response syndrome characterized by cord blood interleukin-6 >11 picogram per milliliter (pg/mL), funisitis, or chorionic vasculitis. The number of participants who experienced at least one AESI has been presented.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	3	5

44. Secondary Outcome

Title	Neonatal APGAR Scores
Description	APGAR is a quick test to assess the health of new born children. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two, then summing up the five values obtained. APGAR score ranges from 0 to 10 where a score of 7 and above is normal. The mean and standard deviation of APGAR scores at one minute and at five minutes of birth has been presented.
Time Frame	Up to 5 minutes after birth

Outcome Measure Data

Analysis Population Description

Neonatal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Mean (Standard Deviation); Unit of Measure: Score on APGAR scale
one minute at birth	7.3 (1.80)	7.5 (1.78)
five minutes at birth	8.5 (1.05)	8.7 (1.06)

45. Secondary Outcome

Title	Weight of Neonates
Description	The weight of neonates was obtained from the neonate birth record. The mean weight of neonates and standard deviation has been presented.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Neonatal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Mean (Standard Deviation); Unit of Measure: grams (g)
	2015.0 (805.67)	2121.2 (681.31)

46. Secondary Outcome

Title	Head Circumference of Neonates
Description	The head circumference was determined from the neonate birth record.
Time Frame	Up to 17 weeks

Outcome Measure Data

Analysis Population Description

Neonatal ITT Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period
Overall Number of Participants Analyzed	13	10
Mean (Standard Deviation); Unit of Measure: centimeters (cm)
	29.57 (2.791)	30.13 (3.059)

47. Secondary Outcome

Title	Number of Neonatal Participants With AEs and SAEs
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one AE and one SAE has been presented. Neonatal Safety Population consisted of neonates whose mothers received randomized treatment.
Time Frame	Up to 28 days after the EDD of 40 weeks gestation

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
AEs	8	7
SAEs	3	5

48. Secondary Outcome

Title	Number of Neonatal Participants With AESI
Description	Neonatal AESI included: Neonatal death; Asphyxia; Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis); RDS; Hypotension; IVH/periventricular leukomalacia; Bronchopulmonary dysplasia; Neonatal acidosis; Hyperbilirubinemia; Necrotizing enterocolitis; and Hypoxic ischemic encephalopathy. The number of neonatal participants who experienced at least one AESI has been presented.
Time Frame	Up to 28 days after EDD of 40 weeks gestation

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	8	5

49. Secondary Outcome

Title	Number of Neonatal Participants With DRE
Description	The disease related neonatal events occurring in Infants born prior to 37 completed weeks included: apnea (severe), respiratory failure due to fatigue, hypoxia, or air leak from alveolar injury, patent ductus arteriosus, bradycardia, ventriculomegaly, cerebellar hemorrhage, hydrocephalus other than congenital, gastroesophageal reflux, aspiration pneumonia, anemia, retinopathy of prematurity (all stages), hearing disorder, temperature instability and hypoglycemia. The number of participants with at least one DRE has been presented.
Time Frame	Up to 28 days after EDD of 40 weeks gestation

Outcome Measure Data

Analysis Population Description

Neonatal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, intravenous (IV) loading dose over 5 minutes and continuous infusion rate for remainder of 48-hour treatment period.Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
	4	2

50. Secondary Outcome

Title	Maternal Length of Stay in Hospital
Description	Details on maternal health care resource use (both for hospitalizations related to preterm labor not resulting in a delivery and hospitalizations related to preterm labor/normal labor resulting in a delivery) associated with an episode of preterm labor, preterm delivery and normal term delivery (>= 37 weeks gestation) were collected from review of medical records. Length of hospital stay associated with hospital admission for preterm labor and normal term labor/term delivery is presented. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. Only participants with data available at the specified time points were analyzed (indicated by n=X) in category titles. NA indicates standard deviation could not be calculated as only one participant was analyzed.
Time Frame	Up to 28 days post EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Mean (Standard Deviation); Unit of Measure: Days
Preterm labor; n=1, 0	Number Analyzed	1 participants	0 participants
		2.642 [1] (NA)
Preterm delivery; n=9, 7	Number Analyzed	9 participants	7 participants
		10.177 (11.9312)	13.583 (20.7670)
Normal term delivery; n=4, 2	Number Analyzed	4 participants	2 participants
		3.719 (2.2309)	4.635 (2.7616)

[1]

Standard deviation could not be calculated as only one participant was analyzed.

51. Secondary Outcome

Title	Number of Participants With Hospital Admissions Related to Preterm Labor and Preterm Delivery
Description	Maternal healthcare resource utilization associated with an episode of preterm labor and preterm delivery were collected from the review of medical records. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. The number of participants who had hospital admission for preterm labor and preterm delivery has been presented. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
Time Frame	Up to 28 days after EDD (40 0/7 weeks of gestation)

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Measure Type: Number; Unit of Measure: Participants
Preterm labor; n=13, 10	Number Analyzed	13 participants	10 participants
		1	0
Preterm delivery; n=13, 9	Number Analyzed	13 participants	9 participants
		9	7

52. Secondary Outcome

Title	Number of Participants Admitted to Particular Hospital Unit
Description	Maternal healthcare resource utilization associated with an episode of preterm labor, preterm delivery and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit has been presented.
Time Frame	Up to 28 days post EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title	Placebo	Retosiban
Arm/Group Description:	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	13	10
Measure Type: Number; Unit of Measure: Participants
General ward	9	2
Private/Semi-private room	3	2
Labor and delivery	2	3
Labor and delivery to post-partum	0	1
Post-partum	0	1
Ward not specified	0	1
Labor ward	0	1
Antenatal ward	0	1
Postnatal ward	0	1

53. Secondary Outcome

Title	Number of Participants With Different Modes of Transportation to Hospital
Description	The means by which the maternal participants were transported to the hospital i.e. ground ambulance/emergency vehicle (gr. amb/emer. veh), air ambulance, family member or other means were obtained from the review of medical records. The number of maternal participants with the corresponding mode of transportation is presented for preterm labor visit and delivery visit. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).
Time Frame	Up to 28 days post EDD (40 0/7 weeks gestation)

Outcome Measure Data

Analysis Population Description

Maternal Safety Population

Arm/Group Title		Placebo	Retosiban
Arm/Group Description:		Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed		13	10
Measure Type: Number; Unit of Measure: Participants
Preterm labor; gr. amb/emer. veh; n=1, 0	Number Analyzed	1 participants	0 participants
		0
Preterm labor; air ambulance; n=1, 0	Number Analyzed	1 participants	0 participants
		0
Preterm labor; family member; n=1, 0	Number Analyzed	1 participants	0 participants
		1
Preterm labor; other; n=1, 0	Number Analyzed	1 participants	0 participants
		0
Delivery; gr. amb/emer. veh; n=5, 5	Number Analyzed	5 participants	5 participants
		2	1
Delivery; air ambulance; n=5, 5	Number Analyzed	5 participants	5 participants
		0	0
Delivery; family member; n=5, 5	Number Analyzed	5 participants	5 participants
		3	3
Delivery; other; n=5, 5	Number Analyzed	5 participants	5 participants
		0	1
Preterm labor;<24 hour stay;gr. amb/emer.veh;n=1,0	Number Analyzed	1 participants	0 participants
		0
Preterm labor; <24 hour stay;air ambulance; n=1, 0	Number Analyzed	1 participants	0 participants
		0
Preterm labor; <24 hour stay;family member; n=1, 0	Number Analyzed	1 participants	0 participants
		1
Preterm labor; <24 hour stay;other; n=1, 0	Number Analyzed	1 participants	0 participants
		0

54. Secondary Outcome

Title	Retosiban Clearance
Description	Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).
Time Frame	Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

Outcome Measure Data

Analysis Population Description

Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).

Arm/Group Title	Retosiban
Arm/Group Description:	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	53
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Liters per hour
	83.4; (5.25%)

55. Secondary Outcome

Title	Volume of Distribution of Retosiban
Description	Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).
Time Frame	Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

Outcome Measure Data

Analysis Population Description

Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).

Arm/Group Title	Retosiban
Arm/Group Description:	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
Overall Number of Participants Analyzed	53
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Liters
	68.6; (109%)

Adverse Events

Time Frame	On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) will be collected from the start of study treatment and until the follow up contact (Up to 6 weeks after delivery).
Adverse Event Reporting Description	SAEs and AEs were analyzed in Maternal Safety Population and Neonatal Safety Population which comprised of mothers randomly assigned to treatment who were exposed to study treatment and neonates whose mothers received randomized treatment.
Arm/Group Title	Placebo (Maternal)	Retosiban (Maternal)	Placebo (Fetal)	Retosiban (Fetal)	Placebo (Neonatal)	Retosiban (Neonatal)
Arm/Group Description	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.	Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment.	Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period.
All-Cause Mortality
	Placebo (Maternal)	Retosiban (Maternal)	Placebo (Fetal)	Retosiban (Fetal)	Placebo (Neonatal)	Retosiban (Neonatal)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Serious Adverse Events
	Placebo (Maternal)	Retosiban (Maternal)	Placebo (Fetal)	Retosiban (Fetal)	Placebo (Neonatal)	Retosiban (Neonatal)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)	3/13 (23.08%)	5/10 (50.00%)
Cardiac disorders
Cardiac arrest † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Congenital, familial and genetic disorders
Ankyloglossia congenital † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Congenital hypothyroidism † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Gastrointestinal disorders
Inguinal hernia † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	2/10 (20.00%)
Meconium plug syndrome † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Infections and infestations
Group B streptococcus neonatal sepsis † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Tracheitis † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Pregnancy, puerperium and perinatal conditions
Umbilical cord prolapse † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)
Psychiatric disorders
Selective eating disorder † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	2/13 (15.38%)	1/10 (10.00%)
1 Term from vocabulary, MedDRA 20.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo (Maternal)	Retosiban (Maternal)	Placebo (Fetal)	Retosiban (Fetal)	Placebo (Neonatal)	Retosiban (Neonatal)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/13 (46.15%)	6/10 (60.00%)	3/13 (23.08%)	5/10 (50.00%)	8/13 (61.54%)	7/10 (70.00%)
Blood and lymphatic system disorders
Anaemia † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Thrombocytopenia † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Cardiac disorders
Foetal heart rate disorder † 1	0/13 (0.00%)	0/10 (0.00%)	2/13 (15.38%)	5/10 (50.00%)	0/13 (0.00%)	0/10 (0.00%)
Foetal heart rate deceleration abnormality † 1	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Eye disorders
Conjunctival haemorrhage † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Gastrointestinal disorders
Constipation † 1	1/13 (7.69%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Abdominal discomfort † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Diarrhoea † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Haemorrhoids † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Inguinal hernia † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	2/13 (15.38%)	2/10 (20.00%)
Haematochezia † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	1/10 (10.00%)
Necrotising colitis † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Vomiting † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
General disorders
Oedema † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Pyrexia † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Granuloma † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Hepatobiliary disorders
Hyperbilirubinaemia neonatal † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	6/13 (46.15%)	4/10 (40.00%)
Jaundice † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	1/10 (10.00%)
Cholestasis † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Infections and infestations
Abscess limb † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Amniotic cavity infection † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Bacterial vulvovaginitis † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Kidney infection † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Viral upper respiratory tract infection † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Device related infection † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Oral candidiasis † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Injury, poisoning and procedural complications
Contusion † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	1/10 (10.00%)
Vaccination complication † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Investigations
Blood calcium decreased † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Blood glucose decreased † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Liver function test increased † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Body temperature fluctuation † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Metabolism and nutrition disorders
Feeding intolerance † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Hypoglycaemia † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Musculoskeletal and connective tissue disorders
Myalgia † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Pain in extremity † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Osteopenia † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Nervous system disorders
Headache † 1	1/13 (7.69%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Intraventricular haemorrhage † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Motor dysfunction † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Pregnancy, puerperium and perinatal conditions
Oligohydramnios † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Uterine contractions abnormal † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Reproductive system and breast disorders
Oedema genital † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Neonatal respiratory distress syndrome † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	2/13 (15.38%)	2/10 (20.00%)
Bronchopulmonary dysplasia † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	3/13 (23.08%)	0/10 (0.00%)
Pleural effusion † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Respiratory acidosis † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Tachypnoea † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus † 1	0/13 (0.00%)	1/10 (10.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Pruritus generalised † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Dermatitis diaper † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Dry skin † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Intertrigo † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Seborrhoea † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
Vascular disorders
Hypertension † 1	1/13 (7.69%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)
Hypotension † 1	0/13 (0.00%)	0/10 (0.00%)	0/13 (0.00%)	0/10 (0.00%)	1/13 (7.69%)	0/10 (0.00%)
1 Term from vocabulary, MedDRA 20.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343
• EMail: GSKClinicalSupportHD@gsk.com

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02377466
• Other Study ID Numbers: 200719; 2014-003326-41 ( EudraCT Number )
• First Submitted: February 26, 2015
• First Posted: March 3, 2015
• Results First Submitted: January 22, 2018
• Results First Posted: July 19, 2018
• Last Update Posted: July 28, 2020